Recall Z-0192-2009 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Barrx Medical, Inc.
Hydrophobic HALO360 Filter that is packaged with HALO360+ Ablation Catheters Model numbers 32041-22, 32041-28, 32041-31 and 32041-34, and/or with HALO360 Sizing Balloon Model number 3441B.
| Date | Oct 31, 2008 (initiated Sep 18, 2008) |
| Status | Terminated |
| Reason | Some units may contain the wrong filter, which does not have the proper lock and may result in a leak. |
| Root cause | Mixed-up of materials/components |
| Action | The recall was initiated on September 18, 2008. All users and international distributors were informed by letter. The replacement filters were sent on 9/19/2008. Contact Barrx Medical, Inc. at 1-408-745-8000 for assistance. |
| Quantity | 650 units |
| Distribution | Worldwide Distribution, including USA, Austria, Australia, Belgium, Canada, France, Netherlands, Switzerland, Sweden, and UK . |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.